1. Field of the Invention
The invention relates to a structure for and method of therapeutic treatment of a body portion requiring maintaining the body portion at a programmed temperature and a method of making the structure.
More specifically, the invention relates to a therapeutic device including a shield for application to a body portion in intimate surface to surface contact therewith and means for regulating the temperature of the shield by passing a fluid therethrough having a temperature maintained in accordance with a predetermined program and/or the temperature of the body portion. The invention also specifically refers to a method of manufacturing the device and the method of therapeutic treatment of the body portion with the device through the application of the shield of the device to the body portion in intimate surface to surface contact therewith.
2. Description of the Prior Art
In the past, devices have been known for cooling or heating a body portion such as a knee, ankle, neck or the like to reduce swelling, to promote healing and to relieve pain. Such devices include ice packs, common splints, neck braces, cooled or heated wraps and the like. They also include devices for cooling or heating of a body portion in accordance with the type of injury and/or surgery and/or the time during a healing cycle of the body portion.
The more sophisticated of the prior art devices sometimes are provided with passages therein, through which a liquid from a fluid reservoir is passed to either heat or cool a body portion. With such devices, the fluid has usually been pumped at an inconsistent temperature or has been circulated without pumping, using a thermosiphon principle.
The known devices of the past are inadequate since they do not conform intimately to the surface of the body portion to be treated, the temperature of which it is desired to control, whereby they are inefficient. Also, they are uncomfortable in that they are not initially molded to the body portion to conform to the shape of the body portion to be temperature controlled and are bulky. In addition, with prior known devices, temperature control has been non-uniform and inconsistent due to poor surface to surface contact between the shield of the device and the body portion.
One such device is found in U.S. Pat. No. 5,411,542. The device as disclosed in this patent is flat and is adapted to be wrapped around ankle and foot body portions. The device has straps for securing it in place, and passages for the passing of fluid therethrough. As indicated above, this device is deficient in that it is not constructed to be in close surface to surface contact with a body portion the temperature of which it is desired to control, and no temperature control means are shown. In fact, no means for circulating the fluid is shown in this disclosure.
The device shown in U.S. Pat. No. 5,411,541 teaches pumping of fluid through a fluid therapy device and control of the fluid temperature. It does not, however, suggest control of the temperature of the body portion in accordance with the flow of the fluid and/or the temperature of the body portion.
The U.S. Pat. No. 5,372,608 merely teaches a thermosiphon employed for circulating fluid through the therapeutic device shown, and does not suggest any control of the temperature of the fluid other than to have frozen particles such as ice in the fluid container.
U.S. Pat. No. 4,745,922 shows a substantially conventional neck brace which is not intended to be in intimate surface to surface contact with the body portion it is intended to immobilize. While U.S. Pat. No. 4,745,922 teaches tubing with heating or cooling fluid passing therethrough, and other articles such as a compress and an ice bag placed in the brace next to the body portion to be treated, no adequate temperature control means is disclosed. Again, the device is strapped to the patient.
None of these prior art devices disclose a shield molded in the shape of a body portion to be treated so as to be in intimate surface to surface contact therewith. Further, these prior art devices do not teach a fluid carrying tube coiled in the shape of a body portion having adjacent portions in surface to surface contact with each other or a gelatinous substance hermetically sealed in a pocket with the coiled tube for the purpose of maintaining the shield in intimate surface to surface contact with the body portion.